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# FDA OKs Array’s Braftovi for Some Cancers
- URL: https://www.fdaweb.com/fda-oks-arrays-braftovi-for-some-cancers/
- Published: 2025-01-06T12:00:00.000Z
- Updated: 2026-09-14T14:50:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158394

FDA has given accelerated approval to Array BioPharma’s Braftovi (encorafenib) with cetuximab (Lilly’s Erbitux) and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation as detected by an FDA-approved test. Array is a Pfizer subsidiary.

An agency [statement](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-encorafenib-cetuximab-and-mfolfox6-metastatic-colorectal-cancer-braf?ref=fdaweb.com) says efficacy was evaluated in the BREAKWATER trial with a major efficacy outcome measure of confirmed objective response rate. FDA says that evaluation of progression-free survival and overall survival in the ongoing BREAKWATER trial will be post-marketing confirmatory evidence for accelerated approval. “This application is an example of the Oncology Center of Excellence’s Project FrontRunner aimed at moving important therapies to earlier disease settings,” the agency says.

The most common adverse reactions were peripheral neuropathy, nausea, fatigue, rash, diarrhea, decreased appetite, vomiting, hemorrhage, abdominal pain, and pyrexia. The most common Grade 3 or 4 laboratory abnormalities were increased lipase and decreased neutrophil count.

The review was conducted under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among international partners. FDA collaborated on this review with Health Canada. The review used the Real-Time Oncology Review pilot program that streamlined data submission before filing of the entire clinical application. It also used the Assessment Aid. It was granted priority review.